Rheumatoid Arthritis. Seropositive Rheumatoid Arthritis
Conditions
Interventions
Intervention 1: The Treatment group will receive ß-D-Mannuronic acid 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substan
Treatment - Drugs
The control group will receive orally 1500 mg/day (three 500 mg tablets/day) of plcebo for 12 weeks.
The Treatment group will receive ß-D-Mannuronic acid 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substance used in food
Sponsors
Vice-Chancellor for Research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Patients should be 18-65 year old, afflicted by Rheumatoid Arthritis, diagnosed based on the American College of Rheumatology (ACR) Diagnostic Criteria by a rheumatology specialist after evaluating the clinical parameters such as ESR, RF, CRP and Anti-CCP. 2.Each patient must sign written informed consent. 3.The disease in all patients should be in active form (DAS28>2.6) 4.None of patients must suffer from another concomitant diseases like Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral diseases. Exclusion Criteria: 1.History of fever and Infectious diseases, positive pregnancy test or lactation, other collagen- vascular diseases, other auto-immune diseases and Malignancies. 2.Enrolling in another clinical trial study within last 4 weeks 3.Suffering from other concomitant diseases such as hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning stiffness. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire.;The number of swollen joints. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Pain. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Examination.;Severity of disease. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Taking history and Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of CRP. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: Turbidometry.;Level of ??ESR. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: See through Westergren method.;Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies. Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: ELISA.;Rheumatoid factor (RF). Timepoint: At baseline and after 12 weeks of treatment. Method of measurement: See through Agglutination. | — |
Countries
Iran (Islamic Republic of), Pakistan
Contacts
Public ContactDr. Abbas Mirshafiey
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Outcome results
None listed